BACKGROUND: Treatment guidelines recommend the use of inhaled corticosteroids in patients with asthma who have persistent symptoms and the "stepping down" of therapy to the minimum needed to maintain control of asthma. Whether patients with asthma that is well controlled with the use of inhaled corticosteroids twice daily can receive a step-down treatment with once-daily montelukast (our primary hypothesis) or once-daily fluticasone propionate plus salmeterol (our secondary hypothesis) has not yet been determined. METHODS: We randomly assigned 500 patients with asthma that was well controlled by inhaled fluticasone (100 μg twice daily) to receive continued fluticasone (100 μg twice daily) (169 patients), montelukast (5 or 10 mg each night) (166 patients), or fluticasone (100 μg) plus salmeterol (50 μg) each night (165 patients). Treatment was administered for 16 weeks in a double-blind manner. The primary outcome was the time to treatment failure. RESULTS: Approximately 20% of patients assigned to receive continued fluticasone or switched to treatment with fluticasone plus salmeterol had treatment failure, as compared with 30.3% of subjects switched to montelukast. The hazard ratio for both comparisons was 1.6 (95% confidence interval, 1.1 to 2.6; P = 0.03). The percentage of days on which patients were free of asthma symptoms (78.7 to 85.8%) was similar across the three groups. CONCLUSIONS: Patients with asthma that is well controlled with the use of twice-daily inhaled fluticasone can be switched to once-daily fluticasone plus salmeterol without increased rates of treatment failure. A switch to montelukast results in an increased rate of treatment failure and decreased asthma control; however, patients taking montelukast remained free of symptoms on 78.7% of treatment days.
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